DISCUSSING TRENDS IN OPDP ENFORCEMENT LETTERS TO AVOID INFRACTIONS

DISCUSSING TRENDS IN OPDP ENFORCEMENT LETTERS TO AVOID INFRACTIONS ; PRODUCT INFO Includes 1 Hour Windows Media Video File and PowerPoint presentations for immediate download. PURCHASE VIDEO According to a recent Office of Prescription Drug Promotion (OPDP) webinar,...

IMPORTANT CHANGES TO THE DRAFT EUROPEAN IVD REGULATION

IMPORTANT CHANGES TO THE DRAFT EUROPEAN IVD REGULATION ; PRODUCT INFO Includes 1 Hour Windows Media Video File and PowerPoint presentations for immediate download. PURCHASE VIDEO In June 2015, the European Council published its much anticipated consolidated draft of...
HOW TO DECIDE WHEN A MODIFIED DEVICE REQUIRES A 510(K) CLEARANCE

HOW TO DECIDE WHEN A MODIFIED DEVICE REQUIRES A 510(K) CLEARANCE

HOW TO DECIDE WHEN A MODIFIED DEVICE REQUIRES A 510(K) CLEARANCE ; PRODUCT INFO Includes 1 Hour Windows Media Video File and PowerPoint presentations for immediate download. PURCHASE VIDEO Determining when a modification to a legally marketed device triggers the need...